Interventions for valvular disease and heart failure

Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial

EuroIntervention 2020;16:833-841. DOI: 10.4244/EIJ-D-20-00303

Nicolas  M. Van Mieghem
Nicolas M. Van Mieghem1, MD, PhD; Michael J. Reardon2, MD; Steven J. Yakubov3, MD; John Heiser4, MD; William Merhi4, DO; Stephan Windecker5, MD; Raj R. Makkar6, MD; Wen Cheng7, MD; Mark Robbins8, MD; Peter Fail9, MD; Edgar Feinberg II9, MD; Robert C. Stoler10, MD; Robert Hebeler11, MD; Patrick W. Serruys12, MD, PhD; Jeffrey J. Popma13, MD
1. Department of Interventional Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands; 2. Department of Cardiothoracic Surgery and Interventional Cardiology, Houston-Methodist-Debakey Heart and Vascular Center, Houston, TX, USA; 3. Department of Cardiology, Riverside Methodist – Ohio Health, Columbus, OH, USA; 4. Departments of Cardiothoracic Surgery and Interventional Cardiology, Spectrum Health Hospitals, Grand Rapids, MI, USA; 5. Department of Interventional Cardiology, University Hospital Bern, Bern, Switzerland; 6. Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA; 7. Cardiac Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA; 8. Interventional Cardiology, Saint Thomas Heart, Ascension Medical Group, Nashville, TN, USA; 9. Interventional Cardiology, Cardiovascular Institute of the South, Houma, LA, USA; 10. Interventional Cardiology, Baylor Scott & White Heart and Vascular Hospital, Dallas, TX, USA; 11. Cardiothoracic Surgery, Baylor Scott & White Heart and Vascular Hospital, Dallas, TX, USA; 12. Department of Cardiology, National University of Ireland, Galway, Ireland; 13. Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA

Aims: In patients with aortic stenosis randomised to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), sex-specific differences in complication rates are unclear in intermediate-risk patients. The purpose of this analysis was to identify sex-specific differences in outcome for patients at intermediate surgical risk randomised to TAVI or SAVR in the international Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial.

Methods and results: A total of 1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR. The population was stratified by sex and treatment modality (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438). The primary endpoint was a composite of all-cause mortality or disabling stroke at two years. Compared to males, females had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs 4.3±1.6%, p<0.01) and were more frail. Men required more concomitant revascularisation (23% vs 16%). All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs 10.5%, p=0.90) and males (14.5% vs 14.4%, p=0.99); the difference between females and males was 10.2% vs 14.5%, for TAVI (p=0.08) and 10.5% vs 14.4%, SAVR (p=0.13). Functional status improvement was more pronounced after TAVI in females than in males.

Conclusions: Aortic valve replacement, either by surgical or transcatheter approach, appears similarly effective and safe for males and females at intermediate surgical risk. Functional status appears to improve most in females after TAVI. Clinical Trial Registration: http://clinicaltrials.gov NCT01586910

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Interventions for valvular diseaseTAVI
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